APPLICATION
ANDA078490
TYPE
ANDA
ORIGINAL APPROVAL
2009-04-17
LATEST ACTION
2023-07-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription
Products
OMEPRAZOLEPrescription
OMEPRAZOLE 10MG · CAPSULE, DELAYED REL PELLETS · ORAL
OMEPRAZOLEPrescription
OMEPRAZOLE 20MG · CAPSULE, DELAYED REL PELLETS · ORAL
OMEPRAZOLEPrescription
OMEPRAZOLE 40MG · CAPSULE, DELAYED REL PELLETS · ORAL
Approval history
2023-07-18Labeling · Supplement 22 · standardAP
2022-03-04Labeling · Supplement 18 · standardAP
2020-12-09Labeling · Supplement 16 · standardAP
2018-06-07Labeling · Supplement 14 · standardAP
2018-05-31Labeling · Supplement 12 · standardAP
2018-05-31Labeling · Supplement 10 · standardAP
2015-03-16Labeling · Supplement 6 · standardAP
2015-03-16Labeling · Supplement 4 · standardAP
2015-03-16Labeling · Supplement 5 · standardAP
2012-03-14Labeling · Supplement 2AP
2012-03-14Labeling · Supplement 1AP
2009-04-17OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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